Glivec OK"d for GIST in Japan, Israel

Drug now approved in U.S., Europe and 70+ nations across the globe

BASEL, Switzerland – Novartis announced July 17 that health authorities in Japan have approved Glivec® (Gleevec/imatinib) for the treatment of patients with c-kit positive gastrointestinal stromal tumors.

The Life Raft Group has independently learned, and Novartis has confirmed, that Israel’s Ministry of Health approved Glivec for GIST treatment July 17. Historically, GIST is very difficult to treat due to its resistance to available chemotherapy and radiation therapy. Previously, surgery was the only treatment option, resulting essentially in palliation of the disease.

The approval from the Japan’s Ministry of Health, Labor and Welfare came only six months after Novartis filed for approval in that country. Glivec was originally granted orphan drug status for the GIST indication in Japan in October 2002. The approval was based on clinical data from studies conducted in Japan and Western countries, including the member states of the European Union and the United States, where Glivec is already approved for GIST.

“This approval enables Japanese patients with kit-positive GISTs to benefit from the remarkable results we’ve seen with Glivec,” said David Epstein, president of Novartis Oncology. “The high response rates in these patients have been extremely encouraging and Novartis is pleased that Japanese regulatory authorities acted swiftly to make the drug available to them.”

The Japanese study of Glivec was conducted in 74 patients who received either 400 mg. or 600 mg. Glivec once a day. The overall response rate was 51 percent at the time of the data cutoff for the submission.

The Japanese data support the findings of a study that was the basis for marketing approval in the EU and U.S. In this open-label, multinational study conducted in 147 patients with unresectable and/or metastatic malignant GISTs, patients were randomized to receive either 400 mg. or 600 mg. of Glivec daily. The overall response was 38 percent, based on confirmed partial responses after a median follow-up of approximately seven months.

Updated data from the multinational study, after a median follow-up of 15 months, was presented in May 2002 at the annual meeting of the American Society of Clinical Oncology (ASCO). The data showed that more than 60 percent of GIST patients achieved a confirmed partial response with Glivec, and an additional 20 percent attained some degree of tumor shrinkage or stabilization of their disease.

The data also revealed that at a median follow-up of 15 months, 73 percent of patients remained on the study.

GISTs are the most common sarcoma of the gastrointestinal tract. According to a Swedish study presented at the American Society of Clinical Oncology meeting held May 31-June 3 in Chicago, the incidence of GIST is estimated at 15 per 1,000,000 people annually, more than three times as high as previously suggested.

Glivec is approved in the U.S., the European Union and more than 70 other countries for the treatment of patients with kit-positive unresectable and/or metastatic malignant GISTs.